Displaying publications 281 - 300 of 390 in total

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  1. Hua LT, Noland RB, Evans AW
    Accid Anal Prev, 2010 Nov;42(6):1934-42.
    PMID: 20728645 DOI: 10.1016/j.aap.2010.05.015
    Recent empirical research has found that there is an inverted U-shaped or Kuznets relationship between income and motor vehicle crash (MVC) deaths, such that MVC deaths increase as national income increases and decrease after reaching a critical level. Corruption has been identified as one of the underlying factors that could affect this relationship, primarily by undermining institutional development and effective enforcement schemes. The total effect of corruption can be decomposed into two components, a direct and an indirect effect. The direct effect measures the immediate impact of corruption on MVC deaths by undermining effective enforcement and regulations, while the indirect effect captures the impact of corruption on hindering increases in per capita income and the consequent impact of reduced income on MVC deaths. By influencing economic growth, corruption can lead to an increase or decrease in MVC deaths depending on the income level. Using data from 60 countries between 1982 and 2003, these effects are estimated using linear panel and fixed effects negative binomial models. The estimation results suggest that corruption has different direct effects for less developed and highly developed countries. It has a negative (decreasing) effect on MVC deaths for less developed countries and a positive (increasing) effect on MVC deaths for highly developed countries. For highly developed countries, the total effect is positive at lower per capita income levels, but decreases with per capita income and becomes negative at per capita income levels of about US$ 38,248. For less developed countries, the total effect is negative within the sample range and decreases with increased per capita income. In summary, the results of this study suggest that reduction of corruption is likely a necessary condition to effectively tackle road safety problems.
    Matched MeSH terms: Safety/standards*
  2. Ahmad R, Abdullah K, Amin Z, Rahman JA
    Auris Nasus Larynx, 2010 Apr;37(2):185-9.
    PMID: 19720483 DOI: 10.1016/j.anl.2009.06.010
    To assess the safety of tonsillectomy procedure in local setting.
    Matched MeSH terms: Safety*
  3. Cheong SM, Totsu S, Nakanishi H, Uchiyama A, Kusuda S
    J Neonatal Perinatal Med, 2016;9(1):99-105.
    PMID: 27002262 DOI: 10.3233/NPM-16915054
    OBJECTIVE: In order to evaluate safety and usefulness of peripherally inserted double lumen central catheter (PIDLCC) in very low birth weight (VLBW) infants, outcomes of VLBW infants who had PIDLCC was studied.

    SUBJECTIVE: Thirty-nine VLBW infants who were admitted to our NICU in 2013 were retrospectively analyzed.

    RESULTS: Mean birth weight and gestational age was 1042.7 gram and 28.5 weeks, respectively. Total duration of indwelling PIDLCC was 1121 days (mean 28.5+18.2 days) with 85 PIDLCCs used. Dressing at the insertion site was done twice weekly with 10% povidone iodine. Four (10.3% with mean of 48 days) infants had catheter-related blood stream infection (CRBSI), with a 3.57 infection per 1000 catheter-day. The mean for days of PIDLCC in 35 infants without CRBSI was 26.5 days. Organisms isolated were Staphylococcus epidermidis, Staphylococcus aureus and Staphylococcus capitis ureolytic. Our study showed significant difference in the duration of indwelling catheter (p = 0.023) and intraventricular hemorrhage (p = 0.043) between the CRBSI group and non-CRBSI group. Five (12.8%) infants had abnormal thyroid function test, in which two infants required thyroxine supplementation upon discharge. However, duration of PIDLCC and abnormal thyroid function test was not statistically significant (p = 0.218). One (2.5%) infant died (death was not related to CRBSI). There was no serious adverse effects secondary to PIDLCC.

    CONCLUSION: It is concluded that the use and maintenance of PIDLCC is safe for VLBW infants, but close monitoring should be observed to detect early signs of infection.

    Matched MeSH terms: Patient Safety*
  4. Jarrar M, Al-Bsheish M, Dardas LA, Meri A, Sobri Minai M
    Int J Health Plann Manage, 2020 Jan;35(1):104-119.
    PMID: 31271233 DOI: 10.1002/hpm.2822
    PURPOSE: In Malaysia, private healthcare sector has become a major player in delivering healthcare services alongside the government healthcare sector. However, wide disparities in health outcomes have been recorded, and adverse events in these contexts have yet to be explored. The purpose of this study was to explore associations between nurse's ethnicity and experience, hospital size, accreditation, and teaching status with adverse events in Malaysian private hospitals.

    METHODS: A cross-sectional survey was conducted in 12 private hospitals in Malaysia. A total of 652 (response rate = 61.8%) nurses participated in the study. Data were collected using self-administered questionnaire on nurses' characteristic, adverse events and events reporting, and perceived patient safety.

    RESULTS: Patient and family complaints events were the most common adverse events in Malaysian private hospitals as result of increased cost of care (3.24 ± 0.95) and verbal miscommunication (3.52 ± 0.87).

    CONCLUSION: Hospital size, accreditation status, teaching status, and nurse ethnicity had a mixed effect on patient safety, perceived adverse events, and events reporting. Policy makers can benefit that errors are related to several human and system related factors. Several system reforms and multidisciplinary efforts were recommended for optimizing health, healthcare and preventing patient harm.

    Matched MeSH terms: Patient Safety/statistics & numerical data
  5. Hassan J, Toh TH, Sivapunniam SK, Hasim R, Ghazali NF, Sulaiman S, et al.
    Pediatr Infect Dis J, 2021 08 01;40(8):774-781.
    PMID: 34250977 DOI: 10.1097/INF.0000000000003164
    BACKGROUND: Incorporating dengue vaccination within existing vaccination programs could help improve dengue vaccine coverage. We assessed the immunogenicity and safety of a quadrivalent human papillomavirus (HPV) vaccine administered concomitantly or sequentially with a tetravalent dengue vaccine (CYD-TDV) in healthy children 9-13 years of age in Malaysia.

    METHODS: In this phase IIIb, open-label, multicenter study (NCT02993757), participants were randomized 1:1 to receive 3 CYD-TDV doses 6 months apart and 2 doses of quadrivalent HPV vaccine concomitantly with, or 1 month before (sequentially), the first 2 CYD-TDV doses. Only baseline dengue-seropositive participants received the 3 doses. Antibody levels were measured at baseline and 28 days after each injection using an enzyme-linked immunosorbent assay for HPV-6, -9, -16 and -18, and the 50% plaque reduction neutralization test for the 4 dengue serotypes; immunogenicity results are presented for baseline dengue-seropositive participants. Safety was assessed throughout the study for all participants.

    RESULTS: At baseline, 197 of 528 (37.3%) randomized participants were dengue-seropositive [n = 109 (concomitant group) and n = 88 (sequential group)]. After the last HPV vaccine dose, antibody titers for HPV among baseline dengue-seropositive participants were similar between treatment groups, with between-group titer ratios close to 1 for HPV-6 and 0.8 for HPV-11, -16, and -18. After CYD-TDV dose 3, dengue antibody titers were similar between treatment groups for all serotypes [between-group ratios ranged from 0.783 (serotype 2) to 1.07 (serotype 4)]. No safety concerns were identified.

    CONCLUSIONS: The immunogenicity and safety profiles of CYD-TDV and quadrivalent HPV vaccines were unaffected when administered concomitantly or sequentially in dengue-seropositive children.

    Matched MeSH terms: Patient Safety*
  6. Zare D, Muhammad K, Bejo MH, Ghazali HM
    J Food Sci, 2015 Feb;80(2):T479-83.
    PMID: 25586500 DOI: 10.1111/1750-3841.12752
    Scombroid fish poisoning is usually associated with consumption of fish containing high levels of histamine. However, reports indicate that some cases have responded to antihistamine therapy while ingested histamine levels in these cases were low. Potentiation of histamine toxicity by some biogenic amines, and release of endogenous histamine by other compounds such as cis-urocanic acid (UCA) are some hypotheses that have been put forth to explain this anomaly. Very little is known about the effects of storage conditions on the production of both UCA isomers and biogenic amines in tuna. Thus, the production of trans- and cis-UCA, histamine, putrescine, and cadaverine in tuna during 15 d of storage at 0, 3, and 10 °C and 2 d storage at ambient temperature were monitored. The initial trans- and cis-UCA contents in fresh tuna were 2.90 and 1.47 mg/kg, respectively, whereas the levels of putrescine and cadaverine were less than 2 mg/kg, and histamine was not detected. The highest levels of trans- and cis-UCA were obtained during 15 d storage at 3 °C (23.74 and 21.79 mg/kg, respectively) while the highest concentrations of histamine (2796 mg/kg), putrescine (220.32 mg/kg) and cadaverine (1045.20 mg/kg) were obtained during storage at room temperature, 10 and 10 °C, respectively. Histamine content increased considerably during storage at 10 °C whereas trans- and cis-UCA contents changed slightly. The initial trans-UCA content decreased during storage at ambient temperature. Thus, unlike histamine, concentrations of trans- and cis-UCA did not result in elevated levels during storage of tuna.
    Matched MeSH terms: Food Safety
  7. Yakub F, Md Khudzari AZ, Mori Y
    Int J Rehabil Res, 2014 Mar;37(1):9-21.
    PMID: 24126254 DOI: 10.1097/MRR.0000000000000035
    This paper presents and studies various selected literature primarily from conference proceedings, journals and clinical tests of the robotic, mechatronics, neurology and biomedical engineering of rehabilitation robotic systems. The present paper focuses of three main categories: types of rehabilitation robots, key technologies with current issues and future challenges. Literature on fundamental research with some examples from commercialized robots and new robot development projects related to rehabilitation are introduced. Most of the commercialized robots presented in this paper are well known especially to robotics engineers and scholars in the robotic field, but are less known to humanities scholars. The field of rehabilitation robot research is expanding; in light of this, some of the current issues and future challenges in rehabilitation robot engineering are recalled, examined and clarified with future directions. This paper is concluded with some recommendations with respect to rehabilitation robots.
    Matched MeSH terms: Patient Safety
  8. Hosseinpour M, Yahaya AS, Sadullah AF
    Accid Anal Prev, 2014 Jan;62:209-22.
    PMID: 24172088 DOI: 10.1016/j.aap.2013.10.001
    Head-on crashes are among the most severe collision types and of great concern to road safety authorities. Therefore, it justifies more efforts to reduce both the frequency and severity of this collision type. To this end, it is necessary to first identify factors associating with the crash occurrence. This can be done by developing crash prediction models that relate crash outcomes to a set of contributing factors. This study intends to identify the factors affecting both the frequency and severity of head-on crashes that occurred on 448 segments of five federal roads in Malaysia. Data on road characteristics and crash history were collected on the study segments during a 4-year period between 2007 and 2010. The frequency of head-on crashes were fitted by developing and comparing seven count-data models including Poisson, standard negative binomial (NB), random-effect negative binomial, hurdle Poisson, hurdle negative binomial, zero-inflated Poisson, and zero-inflated negative binomial models. To model crash severity, a random-effect generalized ordered probit model (REGOPM) was used given a head-on crash had occurred. With respect to the crash frequency, the random-effect negative binomial (RENB) model was found to outperform the other models according to goodness of fit measures. Based on the results of the model, the variables horizontal curvature, terrain type, heavy-vehicle traffic, and access points were found to be positively related to the frequency of head-on crashes, while posted speed limit and shoulder width decreased the crash frequency. With regard to the crash severity, the results of REGOPM showed that horizontal curvature, paved shoulder width, terrain type, and side friction were associated with more severe crashes, whereas land use, access points, and presence of median reduced the probability of severe crashes. Based on the results of this study, some potential countermeasures were proposed to minimize the risk of head-on crashes.
    Matched MeSH terms: Safety
  9. Reddy KR, Farhana NI, Salleh B
    J Food Sci, 2011 May;76(4):T99-104.
    PMID: 22417376 DOI: 10.1111/j.1750-3841.2011.02133.x
    Malaysian population widely consumes the cereal-based foods, oilseeds, nuts, and spices in their daily diet. Mycotoxigenic fungi are well known to invade food products under storage conditions and produce mycotoxins that have threat to human and animal health. Therefore, determining toxigenic fungi and aflatoxin B(1) (AFB1) in foods used for human consumption is of prime importance to develop suitable management strategies and to minimize risk. Ninety-five food products marketed in Penang, Malaysia were randomly collected from different supermarkets and were analyzed for presence of Aspergillus spp. by agar plate assay and AFB1 by enzyme-linked immunosorbent assay (ELISA). A. flavus was the dominant fungi in all foods followed by A. niger. Fifty-five A. flavus strains were tested for their ability to produce aflatoxins on rice grain substrate. Thirty-six (65.4%) strains out of 55 produced AFB1 ranging from 1700 to 4400 μg/kg and 17 strains (31%) produced AFB2 ranging from 620 to 1670 μg/kg. Natural occurrence of AFB1 could be detected in 72.6% food products ranging from 0.54 to 15.33 μg/kg with a mean of 1.95 μg/kg. Maximum AFB1 levels were detected in peanut products ranging from 1.47 to 15.33 μg/kg. AFB1 levels detected in all food products were below the Malaysian permissible limits (<35 μg/kg). Aspergillus spp. and AFB1 was not detected in any cookies tested. Although this survey was not comprehensive, it provides valuable information on aflatoxin levels in foods marketed in Malaysia.
    Matched MeSH terms: Consumer Product Safety
  10. Mohammed Saghir SA, Al-Hassan FM, Alsalahi OS, Abdul Manaf FS, Baqir HS
    J Coll Physicians Surg Pak, 2012 May;22(5):294-7.
    PMID: 22538033 DOI: 05.2012/JCPSP.294297
    To determine the optimum storage temperature and time for prothrombin time and activated partial thromboplastin time at various intervals at both room temperature and refrigerator.
    Matched MeSH terms: Safety
  11. Chik Z, Haron DE, Ahmad ED, Taha H, Mustafa AM
    PMID: 21607892 DOI: 10.1080/19440049.2011.576401
    Migration of melamine has been determined for 41 types of retail melamine-ware products in Malaysia. This study was initiated by the Ministry of Health, Malaysia, in the midst of public anxiety on the possibility of melamine leaching into foods that come into contact with the melamine-ware. Thus, the objective of this study was to investigate the level of melamine migration in melamine utensils available on the market. Samples of melamine tableware, including cups and plates, forks and spoons, tumblers, bowls, etc., were collected from various retail outlets. Following the test guidelines for melamine migration set by the European Committee for Standardisation (CEN 2004) with some modifications, the samples were exposed to two types of food simulants (3% acetic acid and distilled water) at three test conditions (25°C (room temperature), 70 and 100°C) for 30 min. Melamine analysis was carried out using LC-MS/MS with a HILIC column and mobile phase consisting of ammonium acetate/formic acid (0.05%) in water and ammonium acetate/formic acid (0.05%) in acetonitrile (95 : 5, v/v). The limit of quantification (LOQ) was 5 ng/ml. Melamine migration was detected from all samples. For the articles tested with distilled water, melamine migration were [median (interquartile range)] 22.2 (32.6), 49.3 (50.9), 84.9 (89.9) ng/ml at room temperature (25°C), 70 and 100°C, respectively. In 3% acetic acid, melamine migration was 31.5 (35.7), 81.5 (76.2), 122.0 (126.7) ng/ml at room temperature (25°C), 70 and 100°C, respectively. This study suggests that excessive heat and acidity may directly affect melamine migration from melamine-ware products. However the results showed that melamine migration in the tested items were well below the specific migration limit (SML) of 30 mg/kg (30,000 ng/ml) set out in European Commission Directive 2002/72/EC.
    Matched MeSH terms: Food Safety
  12. Gomes C
    Int J Biometeorol, 2012 Nov;56(6):1011-23.
    PMID: 22215021 DOI: 10.1007/s00484-011-0515-5
    This paper addresses a concurrent multidisciplinary problem: animal safety against lightning hazards. In regions where lightning is prevalent, either seasonally or throughout the year, a considerable number of wild, captive and tame animals are injured due to lightning generated effects. The paper discusses all possible injury mechanisms, focusing mainly on animals with commercial value. A large number of cases from several countries have been analyzed. Economically and practically viable engineering solutions are proposed to address the issues related to the lightning threats discussed.
    Matched MeSH terms: Safety
  13. Tamrin SB, Jamalohdin MN, Ng YG, Maeda S, Ali NA
    Ind Health, 2012;50(2):156-63.
    PMID: 22293728
    The objectives of this study are to determine the prevalence of hand-arm vibration syndrome (HAVS) and the characteristics of the vibrotactile perception threshold (VPT) among users of hand-held vibrating tools working in a tropical environment. A cross sectional study was done among 47 shipyard workers using instruments and a questionnaire to determine HAVS related symptoms. The vibration acceleration magnitude was determined using a Human Vibration Meter (Maestro). A P8 Pallesthesiometer (EMSON-MAT, Poland) was used to determine the VPT of index and little finger at frequencies of 31.5 Hz and 125 Hz. The mean reference threshold shift was determined from the reference threshold shift derived from the VPT value. The results show a moderate prevalence of HAVS (49%) among the shipyard workers. They were exposed to the same high intensity level of HAVS (mean = 4.19 ± 1.94 m/s(2)) from the use of vibrating hand-held tools. The VPT values were found to be higher for both fingers and both frequencies (index, 31.5 Hz = 110.91 ± 7.36 dB, 125 Hz = 117.0 ± 10.25 dB; little, 31.5 Hz = 110.70 ± 6.75 dB, 125 Hz = 117.71 ± 10.25 dB) compared to the normal healthy population with a mean threshold shift of between 9.20 to 10.61 decibels. The frequency of 31.5 Hz had a higher percentage of positive mean reference threshold shift (index finger=93.6%, little finger=100%) compared to 125 Hz (index finger=85.1%, little finger=78.7%). In conclusion, the prevalence of HAVS was lower than those working in a cold environment; however, all workers had a higher mean VPT value compared to the normal population with all those reported as having HAVS showing a positive mean reference threshold shift of VPT value.
    Matched MeSH terms: Equipment Safety
  14. Künzi V, Klap JM, Seiberling MK, Herzog C, Hartmann K, Kürsteiner O, et al.
    Vaccine, 2009 Jun 2;27(27):3561-7.
    PMID: 19464535 DOI: 10.1016/j.vaccine.2009.03.062
    Despite the established benefit of intramuscular (i.m.) influenza vaccination, new adjuvants and delivery methods for comparable or improved immunogenicity are being explored. Intradermal (i.d.) antigen administration is hypothesized to initiate an efficient immune response at reduced antigen doses similar to that observed after i.m. full dose vaccination.
    Matched MeSH terms: Safety
  15. Wong LP
    Int J Gynaecol Obstet, 2008 Nov;103(2):131-5.
    PMID: 18768178 DOI: 10.1016/j.ijgo.2008.07.005
    To investigate the acceptability of the HPV vaccine among a multiethnic sample of young women in Malaysia.
    Matched MeSH terms: Safety
  16. Muhamad HB, Ai TY, Sahid IB
    J Environ Sci Health B, 2008 Feb;43(2):134-40.
    PMID: 18246505 DOI: 10.1080/03601230701795072
    The purpose of this study was to develop a method for the determination of fluroxypyr (4-amino-3,5-dichloro-6-fluro2-pyridyloxyacetic acid) residue in palm oil namely crude palm oil (CPO) and crude palm kernel oil (CPKO). The method involves the extraction of the herbicide from the oil matrix followed by low temperature precipitation and finally quantification of the residues using the high performance liquid chromatography (HPLC). The extraction efficiency of the method was evaluated by conducting recovery studies. The recovery of fluroxypyr from the fortified CPO samples ranged from 78%-111% with the relative values for the coefficient of variation ranging from 1.4 to 8.6%. Furthermore, the recovery of fluroxypyr from the spiked CPKO samples ranged from 91-107% with the relative values for the coefficient of variation ranging from 0.6 to 4.5%. The minimum detection limit of fluroxypyr in CPO and CPKO was 0.05 microg/g. The method was used to determine fluroxypyr residues from the field-treated samples of CPO and CPKO. When fluroxypyr was used for weed control in oil palm plantations no residue was detected in CPO and CPKO irrespective of the sampling interval and the dosage applied at the recommended or double the manufacturer's recommended dosage.
    Matched MeSH terms: Consumer Product Safety
  17. Liau KM, Yusof MI, Abdullah MS, Abdullah S, Yusof AH
    Spine (Phila Pa 1976), 2006 Jul 15;31(16):E545-50.
    PMID: 16845341
    A cross-sectional study of thoracic pedicle morphometry (T1-T12) of 180 Malaysian Malay patients obtained from computed tomographic scan.
    Matched MeSH terms: Safety
  18. Ang HH, Lee KL, Kiyoshi M
    Int J Environ Health Res, 2004 Aug;14(4):261-72.
    PMID: 15369991
    The DCA (Drug Control Authority), Malaysia implemented the phase 3 registration of traditional medicines on 1 January 1992 with special emphasis on the quality, efficacy and safety (including the presence of heavy metals) in all pharmaceutical dosage forms of traditional medicinal preparations. As such, a total of 100 traditional medicinal preparations, containing Smilax myosotiflora, in various pharmaceutical dosage forms, which were bought in the Malaysian market, were analysed for lead content using atomic absorption spectrophotometry. Results showed that 15% of the products analysed possessed 10.23-23.05 ppm of lead, and therefore, do not comply with the quality requirement for traditional medicines in Malaysia. The quality requirement for traditional medicines in Malaysia is that they should not exceed 10 ppm of lead. Out of these 15 products, five products exhibited 10.23-23.05 ppm of lead, in fact they have already been registered with the DCA Malaysia. However, the rest of the products, which possessed 12.24-20.72 ppm of lead, have still not been registered with the DCA Malaysia. Although this study successfully showed that only 85% of the products complied with the quality requirement for traditional medicines in Malaysia pertaining to lead, they cannot, however, be assumed to be safe from lead contamination because of batch-to-batch inconsistency.
    Matched MeSH terms: Safety
  19. Mohd Nor MN, Abu Mustapa AJ, Abu Hassan MA, Chang KW
    Rev. - Off. Int. Epizoot., 2003 Aug;22(2):485-97.
    PMID: 15884584
    The Department of Veterinary Services (DVS) in Malaysia was established in 1888 as an agency to control exotic and domestic animal diseases. Over the years, the structure and functions of the organisation have evolved to meet the growing demand for veterinary services. The responsibilities of the Veterinary Services are enshrined in the Constitution of Malaysia. The current organisation of the DVS is structured to achieve the following objectives:---to prevent, control and eradicate animal and zoonotic diseases--to facilitate the growth and development of a strong animal industry--to ensure that animal products for human consumption are wholesome, clean, safe and suitable to be consumed--to facilitate the growth and development of the animal feed industry--to ensure the welfare and well-being of all animals. To meet these objectives the DVS has nine different divisions, as follows: Planning and Evaluation, Epidemiology and Veterinary Medicine, Veterinary Public Health, Research and Development, Industry Development, Production and Development of Genetic Resources, Human Resource Development (HRD), Enforcement, and Administration. The development of the animal industry is managed through national development policies, including the Third National Agriculture Policy. The basis for current programmes for disease control and animal industry development is the Eighth Development Plan (2001-2005). Over the period of this Plan, Malaysia will address the need for sanitary and phytosanitary measures by developing specific programmes covering all fields of the animal industry. This is just one way in which Malaysia is meeting the challenges of the increased liberalisation of trade created by the World Trade Organization and the Association of Southeast Asian Nations Free Trade Area. The development of the industry is focused on the major commodities, namely, beef, mutton, poultry meat, eggs, pork and milk. Other commodities receive support if it is considered economically viable. All support services are being strengthened, particularly the HRD division. The organisation and functions of the DVS are constantly being reviewed in accordance with changes in the animal industry and the nature of the services in demand.
    Matched MeSH terms: Consumer Product Safety
  20. Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, et al.
    N Engl J Med, 2016 Feb 11;374(6):533-41.
    PMID: 26551877 DOI: 10.1056/NEJMoa1511643
    BACKGROUND: A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead.
    METHODS: In a prospective multicenter study without controls, a transcatheter pacemaker was implanted in patients who had guideline-based indications for ventricular pacing. The analysis of the primary end points began when 300 patients reached 6 months of follow-up. The primary safety end point was freedom from system-related or procedure-related major complications. The primary efficacy end point was the percentage of patients with low and stable pacing capture thresholds at 6 months (≤2.0 V at a pulse width of 0.24 msec and an increase of ≤1.5 V from the time of implantation). The safety and efficacy end points were evaluated against performance goals (based on historical data) of 83% and 80%, respectively. We also performed a post hoc analysis in which the rates of major complications were compared with those in a control cohort of 2667 patients with transvenous pacemakers from six previously published studies.
    RESULTS: The device was successfully implanted in 719 of 725 patients (99.2%). The Kaplan-Meier estimate of the rate of the primary safety end point was 96.0% (95% confidence interval [CI], 93.9 to 97.3; P<0.001 for the comparison with the safety performance goal of 83%); there were 28 major complications in 25 of 725 patients, and no dislodgements. The rate of the primary efficacy end point was 98.3% (95% CI, 96.1 to 99.5; P<0.001 for the comparison with the efficacy performance goal of 80%) among 292 of 297 patients with paired 6-month data. Although there were 28 major complications in 25 patients, patients with transcatheter pacemakers had significantly fewer major complications than did the control patients (hazard ratio, 0.49; 95% CI, 0.33 to 0.75; P=0.001).
    CONCLUSIONS: In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).
    Matched MeSH terms: Equipment Safety
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